San Diego, CA -- (SBWIRE) -- 08/10/2021 -- An investor, who purchased NASDAQ: CRMD shares, filed a lawsuit against CorMedix Inc over alleged violations of Federal Securities Laws.

Investors who purchased shares of CorMedix Inc. (NASDAQ: CRMD) have certain options and for certain investors are short and strict deadlines running. Deadline: September 20, 2021. NASDAQ: CRMD investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Berkeley Heights, NJ based CorMedix Inc., a biopharmaceutical company, focuses on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the United States and internationally. In July 2020, CorMedix Inc. completed submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for DefenCath as a catheter lock solution with an initial indication for use of preventing CRBSIs in patients with end-stage renal disease who are receiving hemodialysis via a central venous catheter.

On March 1, 2021, CorMedix Inc. (NASDAQ: CRMD) issued a press release "announc[ing] that the [FDA] cannot approve the [NDA] for DefenCath . . . in its present form." CorMedix informed investors that the "FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility"; that the "FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns"; that, "[w]hen we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution"; and that, "[a]dditionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications."

Then, on April 14, 2021, CorMedix Inc. (NASDAQ: CRMD) announced that it would have to take additional steps to meet the FDA's requirements for DefenCath's manufacturing process, including "[a]ddressing FDA's concerns regarding the qualification of the filling operation [that] may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath."

Shares of CorMedix Inc. (NASDAQ: CRMD) declined from $18.80 per share on February 19, 2021, to as low as $5.40 per share on May 14, 2021.

The plaintiff claims that between July 8, 2020 and May 13, 2021, the Defendants made material misrepresentations concerning the following: (i) deficiencies existed with respect to DefenCath's manufacturing process and/or at the facility responsible for manufacturing DefenCath; (ii) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for CRBSIs in its present form; (iii) Defendants had downplayed the true scope of the deficiencies with DefenCath's manufacturing process and/or at the facility responsible for manufacturing DefenCath; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of CorMedix Inc. (NASDAQ: CRMD) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.